Switch to adalimumab in patients with Crohns disease controlled by maintenance infliximab: prospective randomised SWITCH trial
Assche GV et al. – Elective switching from infliximab to adalimumab is associated with loss of tolerance and loss of efficacy within 1 year. Adherence to the first anti–tumour necrosis factor(TNF) agent is recommended.Methods
- An open–label randomised single–centre trial recruited 73 patients with ongoing response to at least 6 months of scheduled maintenance infliximab.
- Patients were randomised to continue intravenous 5 mg/kg infliximab or to switch to subcutaneous adalimumab 80 mg at baseline followed by 40 mg every other week for 1 year.
- Dose optimisation was allowed for intermittent flares, and patients with loss of response or intolerance could cross over to the alternative treatment group.
- Tolerability, patient preference and efficacy of both treatment options were the primary outcomes.
- Dose optimisation or interruption of treatment occurred in 17/36 patients (47%) in the adalimumab group and in 6/37 patients (16%) in the infliximab group (p=0.006).
- One patient interrupted infliximab treatment and 10 patients interrupted adalimumab treatment (p=0.003), mostly for loss of tolerance.
- Overall, patients preferred adalimumab treatment.
- All five serious adverse events were related to complicated Crohn's disease and occurred in patients randomised to adalimumab.
- Injection site reactions were more frequent than infusion reactions (8 vs 1, p=0.01), but only the latter caused cessation of further dosing.
- Anti–TNF serum levels were stable throughout the 1–year period in both groups.